Feasibility Trial of Extracorporeal Iron Purification in Patients With Myelodysplastic Syndrome or Myelofibrosis
Key claim: The MEXIRON feasibility trial evaluates the MEX-CD1 extracorporeal iron chelation device as a novel alternative to oral chelation therapy for reducing iron overload in transfusion-dependent MDS and myelofibrosis patients.
Abstract
In transfusion-dependent myelodysplastic syndromes patients, regular blood transfusions lead to iron overload, which can cause organ damage, hormonal imbalances, and increased infection risk, ultimately impacting patient survival. Standard oral iron chelation therapies can be intolerable for some patients due to adverse effects. The MEX-CD1 device (class III) could potentially offer an alternative for these patients by reducing serum iron levels through a novel, extracorporeal approach.
MEXIRON clinical investigation focuses on the use of MEX-CD1, a medical device designed for extracorporeal chelation therapy to reduce iron overload in patients suffering from transfusion-dependent myelodysplastic syndromes (MDS) and myelofibrosis.
MEXIRON aims to evaluate the device’s use feasibility, safety, and effectiveness in reducing iron levels. Transfusions needs, patient experience and quality of life are also assessed.
Each enrolled patients will undergo three low-volume continuous veno-venous haemodialysis cycles within one week.
Following the three- haemodialysis cycles, patients will be monitored through on-site follow-up visits at 7 days, 28 days, and 90 days post-treatment to assess long-term effects.
Why this matters
Iron overload from chronic transfusion dependence is a major morbidity driver in both myelofibrosis and MDS/MDS-MPN overlap, yet oral chelators are frequently dose-limited by GI and renal toxicity. MEX-CD1 introduces a fundamentally different mechanism — extracorporeal iron purification via CVVHD — opening a non-pharmacologic route that could particularly benefit cytopenic PMF patients where systemic chelator tolerance is poor. If feasible, this would diversify the iron/anemia-axis toolkit alongside hepcidin-targeting (DISC-0974) and erythroid-maturation (luspatercept) strategies.